FDA.reportPublic FDA data

Texaclear Fast Acting Allergy Relief

Product NDC
58809-360
11-digit product format
588090360
Labeler code
58809
Product ID
58809-360_42b3cfc3-8903-edc1-e063-6394a90aa6fe
Type
HUMAN OTC DRUG
Nonproprietary name
Chlophedianol Hydrochloride, Pyrilamine Maleate
Dosage form
LIQUID
Route
ORAL
Labeler
GM Pharmaceuticals, INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-21
Substance
CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE
Active strength
25; 50 mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Texaclear Fast Acting Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLOPHEDIANOL HYDROCHLORIDE25 mg/30mL
PYRILAMINE MALEATE50 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
69QQ58998YInternal UNII lookup
R35D29L3ZAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2672917Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
17a2f643-fa98-21ee-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58809-360-08Texaclear Fast Acting Allergy Relief237 mL in 1 BOTTLE, PLASTICLIQUID23712

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLOPHEDIANOL HYDROCHLORIDEACTIVE INGREDIENT69QQ58998YTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PYRILAMINE MALEATEACTIVE INGREDIENTR35D29L3ZATEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
CHLOPHEDIANOLACTIVE MOIETY42C50P12APTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PYRILAMINEACTIVE MOIETYHPE317O9TLTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58809-360TEXACLEAR FAST ACTING ALLERGY RELIEF (CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE) LIQUID [GM PHARMACEUTICALS, INC]9Current NDC, Legacy NDC, 1 package rows20241009_17a2f643-fa98-21ee-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLArmy & Air Force Exchange Service3d7109a5-4fe1-039b-e063-6394a90a13922025-08-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3d710deb-e42d-13eb-e063-6394a90a56e12025-08-28WarningsExact identifier
application number: M012
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
application number: M012
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
application number: M012
Adult Bisolvine AdultGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.8cde5e39-a338-45af-b847-3823627f29c52025-08-25WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
application number: M012
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLVerityRx9ca6c0f8-71d1-4953-8e98-3311c46640112025-08-22WarningsExact identifier
application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum StrengthPHENYLEPHRINE HCLSalado Sales, Inc.9056fa58-d6aa-4df5-97e0-9be3f2332f862025-08-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
application number: M012
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2672917chlophedianol HCl 25 MG / pyrilamine maleate 50 MG in 30 mL Oral SolutionPSN17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 0.833 MG/ML / pyrilamine maleate 1.67 MG/ML Oral SolutionSCD17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 12.5 MG / pyrilamine maleate 25 MG per 15 ML Oral SolutionSY17a2f643-fa98-21ee-e054-00144ff88e8812
2672917chlophedianol hydrochloride 25 MG / pyrilamine maleate 50 MG per 30 ML Oral SolutionSY17a2f643-fa98-21ee-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58809-360-0858809036008237 mL in 1 BOTTLE, PLASTIC (58809-360-08) 237 ml2014-10-210000-00-00NoNoCurrent